| Objective:To observe the 9 taste Rhizoma et Radix Notopterygii soft capsule on the treatment of respiratory tract infection (cold wet cold folder levy) the clinical efficacy and taste of nine Rhizoma et Radix Notopterygii the safety of soft gelatin capsules for clinical use to provide a scientific basis.Methods:Western medicine consultation with upper respiratory tract infection and the standard of Chinese medicine off a cold wet cold folder with the levy of 48 cases, a district group randomized, double-blind, double-simulation, the positive drug control parallel, multi-center experiment, divided into control and treatment Group. The control group of 24 cases, of which 15 cases of men, nine cases of women aged 20 to 61-year-old, the average age was 37.8 years;Course of three days; illness is mild, five cases, 16 patients with moderate to severe those three cases. The treatment group of 24 cases, of which 13 cases of men, 11 women aged 18 to 60-year-old, the average age was 36.4 years; course of three days; illness is mild, six cases, 16 patients with moderate to severe those two cases. Two groups of patients with gender, age, disease, the severity of Statistics Office Li, no significant difference, comparable. The control group nine flavor Rhizoma et Radix Notopterygii Nong Suwan, 4.5 g / times (4.5 g / bag), 3/9, and taste Rhizoma et Radix Notopterygii soft capsule simulation of 6 / time, 3 times / day, experimental group nine flavor Rhizoma et Radix Notopterygii soft capsule 6 / times, (0.6g / bag), three times / day, plus nine simulation of taste Rhizoma et Radix Notopterygii Nong Suwan, 4.5g / times (4.5 g /Three bags), three times / day, orally. Two courses are three days. Drug cases were observed before and after the clinical symptoms and signs, such as chest X-ray examination of the changes and a comprehensive clinical evaluation. All patients in the trial shall not use any other merger of the upper respiratory tract infection with the treatment of antibacterial, antiviral drugs. The statistical analysis uses the statistical analysis to use the SPSS10.0 statistics software, the grouped data with the chi-square test, the ranked data examines with Ridit, the measurement material uses the T-test.Results:(1) . Comparison of the two groups, treatment group, the total efficiency of 91.67 percent, the control group, the total efficiency of 87.50 percent, the difference was not significant (P> 0.05), equivalent to the effect of the treatment group the control group.(2) . Syndrome effect of the two groups of Chinese medicine, treatment group, the total efficiency of 91.66 percent, the control group, the total efficiency of 91.66 percent, the difference was not significant (P> 0.05), the treatment group effect equivalent to the control group, a single individual Syndrome efficacy of Chinese medicine No differences were significant (P> 0.05), the treatment group effect equivalent to the control group.(3) . Two groups of patients with body temperature of the onset time and antipyretic drugs compare to the first three days, two groups were significantly effect, the control group from the efficiency of 99.11 percent, to the efficiency of the treatment group from 100.00%, between the two groups showed no significant Differences in the treatment group antipyretic rate was 91.96 percent, the control group rate of 93.86 percent antipyretic, between the two groups showed no significant difference. Before and after contrast administration can be seen in the reduction of drug tests rely on a cold wet cold of the patients with body temperature has a prominent role, and the pilot group and the effect of a control group.(4). Safety evaluation test of the treatment and control groups did not withdraw from the case because of adverse events. Before and after treatment Two cases of blood, urine, fecal conventional, liver and kidney function and electrocardiogram did not change significantly, suggesting that the treatment group and control group of drug safety are good.Conclusion:This study uses a randomized, double-blind, double-dummy, the positive drug controls test methods. Statistical analysis using statistical analysis software used SPSS13.0 statistics, disaggregated data by x~2 testing,, measurement data used t-test., grading information with the Ridit test . Statistics show that: (1) in two groups by gender, age, disease, the severity comparable (2) two groups of patients before treatment symptoms, signs the main levy, the levy, tongue veins are comparable, (3) The effect of two groups of patients, the efficacy of Chinese medicine syndrome, the symptoms and signs of decline in value of points, after a single treatment effects of Chinese medicine syndrome there was no significant difference. (4) patients were temperature and antipyretic effect from the time showed no significant difference (5) suggested that the treatment group and control group of drug safety are good. After this clinical trial results showed that the nine soft capsule Rhizoma et Radix Notopterygii taste of upper respiratory tract infection (cold rely on wetlands permits), a table of cold-dispelling, Huashi the role of pain, fever, the evil wind, headaches, body pain and other symptoms of Better treatment. The total effect of Chinese medicine syndrome improve, security in both good results, compared with the control group, no statistically significant difference. |
